Apparatus, system and method for administration of a substance

ABSTRACT

The present disclosure relates to an infusion control valve adapted to be actuated by a valve actuator. The present disclosure further relates to an infusion valve actuator adapted to actuate an infusion control valve upon being triggered by an authentication unit. Furthermore, the present disclosure relates to methods for the administration of a substance.

FIELD OF THE INVENTION

The present disclosure relates to an infusion control valve adapted tobe actuated by a valve actuator. The present disclosure further relatesto an infusion valve actuator adapted to actuate an infusion controlvalve upon being triggered by an authentication unit. Furthermore, thepresent disclosure relates to methods for the administration of asubstance.

BACKGROUND

The parenteral administration of medications, vitamins, pharmaceuticals,fluids, and the like are among the common medical, therapeutic orsimilar health or lifestyle interventions with an approximated more thanone million infusions daily in the United States. Among the substancesthat are often administered intravenously, for example, arechemotherapeutic agents, antibiotics, anesthetics, blood and bloodcomponents, vitamins, minerals, fluids (such as blood plasma, salinesolution, and the like) and total parenteral nutrition (TPN).Chemotherapeutic agents may also be administered by the intrathecalroute. When administering a substance by the parenteral route, criticalfactors affecting safety and efficacy include the proper identificationof the substance (such as a drug, a pharmaceutical composition, blood, ablood product, a blood component, plasma, a plasma derivative, abiological substance, total parenteral nutrition or the like), the dose,the rate, timing and route of administration and the like. Errors inthese parameters or worse—the administration of parenteral drugs to thewrong patient—will often cause serious side effects, including in somecases, death.

In its landmark 1999 report—To Err is Human: Building a Safer HealthSystem by Kohn L T, Corrigan J M, Donaldson M S, eds. National AcademyPress, Washington, D.C., incorporated herein by reference, the UnitedStates Institute of Medicine indicated that medical errors currentlyresult in more than 50,000 deaths annually, making it the 8^(th) leadingof cause of death in the United States, greater than motor vehicleaccidents, breast cancer and AIDS. The overall cost of such medicalerrors was estimated to be between $17-29 billion per year. Sixty-one(61%) of the most serious and life-threatening potential adverse effectswere related to the intravenous administration of drugs. Thus, errors inintravenous drug administrations were common, and were reported to occurin nearly 50% of instances of intravenous administrations; approximately1% of these errors were considered potentially severe (Taxis K, BarberN. Ethnographic study of incidence and severity of intravenous drugerrors. Brit J Med 326:684, 2003). Similarly, in pediatric inpatientsintravenous (IV) medication errors accounted for up to 54% of adversedrug events (Kaushal R, Bates D W, Landrigan C, et al. Medication errorsand adverse drug events in pediatric inpatients. JAMA 285:2114-2120,2001). The majority of these noted errors occurred at the times of theintravenous administration, and virtually all were reportedly due tohuman error.

Blood transfusion is a more complex endeavor than the usual intravenousdrug infusion because a patient's blood sample must be provided forblood typing before the substance (blood or blood components) isadministered. Errors have been found to be frequent in blood transfusion(Sazama K. Reports of 355 transfusion-associated deaths” 1976-1985.Transfusion 30:583-590, 1990, incorporated herein by reference). Thus,in one ongoing surveillance study in the transfusion arena—The SeriousHazards of Transfusion (SHOT) study, Serious Hazards of Transfusion(SHOT), Annual Report, 2003, incorporated herein by reference, which wasimplemented in the UK between the years 1996-2003, more than 66% of allserious hazards resulted from incorrect blood component administration(1,451 events out of 2,191 serious incidents reported) (Serious Hazardsof Transfusion (SHOT), Annual Report, 2003, incorporated herein byreference). In another study Linden J V, Wagner K, Voytovich A E,Sheehan J. Transfusion errors in New York State: an analysis of 10years' experience. Transfusion 40:1207-1213, 2000, incorporated hereinby reference, which reviews transfusion errors in New York State over a10-year period, it was found that the erroneous administration of bloodoccurred in 1/14,000 transfusion. With approximately 12 million bloodtransfusions reportedly administered in the United States annually, thisextrapolates to nearly a thousand estimated erroneous transfusionsannually in the United States alone. In that study, about 50% of errorsoccurred outside the blood bank, usually at the patient's bedside, andmore than 90% were caused by human mistakes (such as administration ofunit(s) of blood to the wrong patient).

SUMMARY

In one embodiment, the invention provides an authentication unitincluding, inter alia, a patient details acquisition unit, a liquidcharacteristics acquisition unit, a comparison unit adapted to calculatea correlation value between the details and the characteristics and avalve actuator control unit adapted to trigger an infusion valveactuator if the correlation value is higher than a predeterminedthreshold value (V_(th)).

In another embodiment, the invention provides an infusion control valveadapted to be actuated by a valve actuator, wherein the valve actuatoris adapted to be triggered by an authentication unit.

In another embodiment, the invention provides an infusion valve actuatoradapted to actuate an infusion control valve upon being triggered by anauthentication unit.

In another embodiment, the invention provides a method for delivering aninfusion including, inter alia, triggering an infusion valve actuatoradapted to actuate an infusion control valve.

DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically shows a basic information system, according toembodiments of the invention.

FIG. 2 schematically shows a basic identification system, according toembodiments of the invention.

FIG. 3 schematically shows the operation of the activation device(“Smart Card”), the valve (in a closed position) located above the dripchamber and the infusion bag, according to embodiments of the invention.

FIG. 4 schematically shows the triggering of the activation device, by ahand-held computer, while the activation device is connected to thevalve, according to embodiments of the invention.

FIG. 5 schematically shows the disconnection of the activation deviceafter the actuation of the valve which now allows the infusion to flow,according to embodiments of the invention.

FIG. 6a illustrates a shutoff device, positioned below the drip chamber,according to embodiments of the invention.

FIG. 6b illustrates a shutoff device, positioned above the drip chamber,according to embodiments of the invention.

FIG. 7 illustrates a shutoff device, according to embodiments of theinvention.

FIG. 8 illustrates a shutoff device, according to embodiments of theinvention.

FIG. 9 illustrates a cross section of a shutoff device, according toembodiments of the invention.

FIG. 10 illustrates a cross section of a shutoff device, according toembodiments of the invention.

FIG. 11 illustrates a cross section of a shutoff device, according toembodiments of the invention.

FIG. 12 illustrates a cross section of a shutoff device, according toembodiments of the invention.

FIG. 13 illustrates a cross section of a shutoff device, according toembodiments of the invention.

FIG. 14 shows a key according to embodiments of the invention.

FIG. 15 illustrates a shutoff device, according to embodiments of theinvention.

FIG. 16 illustrates a cross section of a shutoff device, according toembodiments of the invention.

FIG. 17 shows a typical infusion kit.

FIG. 18 shows an add-on shutoff device according to embodiments of theinvention.

FIG. 19 shows a flowchart of a method according to embodiments of theinvention.

FIG. 20 shows a flowchart of a method according to embodiments of theinvention.

DETAILED DESCRIPTION

Numerous specific details are set forth herein in order to provide athorough understanding, however, it will be understood by those ofordinary skill in the art that the present technology may be practicedwithout the specific details disclosed herein. In other instances,well-known methods, procedures, components, devices, systems andcircuits, whether incorporated or related may be merely referenced orotherwise not have been described in detail so as not to obscure thepresent disclosure.

Errors in parenteral drug administration are common and can lead tomorbidity and mortality. These errors place an unnecessary andextraordinary burden on the healthcare system both in human terms andfinancial costs. The vast majority of errors are simply due to humanmistakes which are correctable, or at least ameliorated, by takingcertain critical tasks in parenteral drug administration out oferror-prone human hands.

Devices, methods and/or systems according to some exemplary embodimentsmay be implemented to assure safety in the parenteral, intravenous orthe like administration of substances such as drugs, pharmaceuticals orthe like by inhibiting their administration, for example, until one ormore (preselected, threshold or dynamic) criteria are met, For example,the parenteral administration of drugs may be inhibited (using forexample, mechanical means, a magnetic interlock, an electro-mechanicalsolenoid or any other appropriate means of inhibition) until one or moreof the following events have taken place and/or have been verified:

-   -   1. The physician's specific orders for a specific patient have        been written and entered into a computer or other control        system.    -   2. The substance the patient is about to receive is identified,        for example, electronically, and verified, for example, for        accuracy of contents, dosage and/or time of administration, and        the like.    -   3. The patient is identified electronically and is found to be        “compatible” with the drug and/or its particulars (for example,        dose, sequence with other drugs, rate of administration, time of        administration and the like).

In accordance with embodiments of the invention, an activation devicemay be, for example, is automatically actuated which in turn will open aclosed Shutoff Device (“Smart Valve”), permitting the patient to receivethe parenteral medicine, for example, once one or more of theseparameters have been verified. Conversely, the Shutoff Device may remainin the closed position and the patient may not be able to receive thedrug, for example, if the intended recipient of the infusion/transfusionis the wrong patient, and/or the drug is incorrect in kind, dosage ortiming. In this manner, the majority and the most severe errors ofparenteral drug administration may be prevented.

In addition, systems, methods and/or devices according to some exemplaryembodiments of the invention may be implemented to collect and/or storeinformation that may be utilized for the overall, long-term managementof the patient's parenteral drug program. This may include, for example,a library of acceptable drug dosages and protocols, precise drugadministration history, records of who were the caregivers for eachtherapeutic event, drug side effects, and/or other critical informationand records. This may also help to prevent errors and may assist themedical staff in monitoring the patient's progress and in planningfuture therapeutic events.

Devices, methods and/or systems according to some exemplary embodimentsof the invention may include one or more of the following elements, forexample, to assure infusion/transfusion safety:

-   -   1. A data authentication unit which may include, inter alia, one        or more of the following elements:        -   an information containing system;        -   a data acquisition unit (which may include, inter alia, a            patient details acquisition unit, a liquid characteristics            acquisition unit or a combination thereof);        -   a comparison unit (which may also be referred to as an            identification system); and        -   a valve actuator control unit.    -   2. An infusion valve actuator (may also be referred to as an        infusion activation device or a “Smart Activator”).    -   3. An infusion control valve (may also be referred to as an        infusion Shutoff Device or a “Smart Valve”).        A Data Authentication Unit

In one embodiment, the invention provides an authentication unitincluding, inter alia, a patient details acquisition unit, a liquidcharacteristics acquisition unit, a comparison unit adapted to calculatea correlation value between the details and the characteristics and avalve actuator control unit adapted to trigger an infusion valveactuator if the correlation value is higher than a predeterminedthreshold value.

In another embodiment, the control unit is adapted to remotely triggerthe infusion valve actuator.

In another embodiment, the patient details may include, inter alia,patient's identification number, patient's Social Security Number, age,gender, diagnosis, substances to which the patient is allergic,diseases, physical conditions, origin, medical history, physician'sorders or any combination thereof. In another embodiment, the patientdetails may include, inter alia, administration details. In anotherembodiment, the administration details comprise dosage, timing ofadministration, rate of administration, sequence of administration withother drugs or any combination thereof.

In another embodiment, the liquid characteristics may include, interalia, liquid type, content, quantity, intended dosage form, volume,color, density, turbidity, contra indications or any combinationthereof.

In another embodiment, the liquid may include, inter alia, saline, adrug, a pharmaceutical composition, blood, a blood product, a bloodcomponent, plasma, a plasma derivative, a biological substance, totalparenteral nutrition (TPN) or any combination thereof. In anotherembodiment, the drug may include, inter alia, a chemotherapeutic agent,antibiotics, anesthetics or any combination thereof.

In one embodiment of the invention, the patient details acquisition unitmay include, inter alia, means of bar-code, RFID, fingerprintsidentification, retinal identification, any combination thereof or anyother appropriate means of identification.

In another embodiment, the liquid characteristics acquisition unit mayinclude, inter alia, means of bar-code, RFID, any combination thereof orany other appropriate means of identification.

In another embodiment, the authentication unit may be located in a handheld computer, stationary computer or a combination thereof. In anotherembodiment, any data related to the invention may be stored on a disk onkey.

In another embodiment, the comparison unit may include, inter alia, aprocessing unit.

In another embodiment, the terms remotely trigger, remotely triggering,remotely triggered and the like, may include inter alia, means of IR(Infra Red), RF (Radio Frequency), ultrasound, any combination thereofor any other means of remotely triggering. In another embodiment, theremotely triggering may be done using Bluetooth.

In another embodiment, the valve actuator may be adapted to actuate aninfusion control valve upon being triggered by the actuator controlunit.

According to some exemplary embodiments of the invention, FIG. 1describes a portion of the data acquisition and the informationcontaining systems. A physician may enter orders for a specific patientinto a computer. The computer may be of a standard format, a hand-helddevice, or another electronic device of similar capabilities. Thecomputer may have, or may receive, for example, a unique patientidentifier such as a bar-code readable number, which may be a SocialSecurity Number, and identification number or any other uniqueidentifier. In addition, other basic patient information such as, butnot necessarily limited to, date of birth, gender, diagnosis, and pastmedication history may be found in the information system.

According to some exemplary embodiments of the invention, for parenteralinfusions and/or transfusions the physician may enter the medications tobe administered, dosages, date, time, route and duration ofadministration, and sequence of administration (if necessary). Theinformation system may also contain a library of accepted protocols anddosages to assure that the physician has entered his ordersappropriately. The physician's drug orders may be transferred to ahand-held device as illustrated in FIG. 1, in accordance withembodiments of the invention.

According to some exemplary embodiments of the invention, FIG. 2illustrates a portion of the patient's identification system. Patient'sidentification according to some exemplary embodiments of the invention.In the illustration, the hand-held device may be used to scan thepatient's wristband to identify which patient is to be treated, forexample, when the infusion or transfusion is ready to be administered.In this illustration, a bar-code identification system is shown, but theinvention is not limited to bar-code reading only, and other methods ofidentification may be used.

The identifier on the patient (for example, bar-code or RFID tag), maybe placed on the wrist during hospital admission or at any other timeprior to the planned infusion or transfusion. In some environments, theinformation system may generate the unique identifier that will beplaced on the patient. Additionally or alternatively, inherent patientidentifiers such as fingerprints, retinal scans or other appropriateidentifiers may be used as well.

Once the patient is identified, the drug to be administered is similarlyidentified by scanning the infusion bag. This is illustrated in FIG. 3,according to some exemplary embodiments of the invention. The scanningmay identify the medication and the dose present in the bag and willlikely be appended by the person preparing the infusion. In FIG. 3 abar-code identification system is shown, but other information methodscan also be employed. This identification may be implemented tocorrelate the drug to be administered with the patient. The informationmay transmitted back to the hand-held device to assure that the specificpatient is due to get the specific medication, at this dose and at thistime, for example, after both the patient and the medication arescanned. This may be performed, for example, by checking, for example,electronically, the information in the computer with the scanninginformation.

An Infusion Valve Actuator (Infusion Activation Device or “SmartActivator”)

In one embodiment, the invention provides an infusion valve actuatoradapted to actuate an infusion control valve upon being triggered by anauthentication unit.

In another embodiment, the actuator is adapted to actuate the valve uponbeing remotely triggered by the authentication unit.

In another embodiment, the infusion valve actuator may be adapted toactuate the infusion control valve by mechanical, electrical,electromechanical, magnetic means or any combination thereof. In anotherembodiment, the infusion valve actuator may be adapted to remotelyactuate the infusion control valve.

In another embodiment, the infusion valve may be adapted to allow theflow of the infusion liquid upon being actuated. In another embodiment,the infusion valve may be adapted to inhibit the flow of the infusionliquid when the valve is not actuated.

In another embodiment, the infusion control valve may include, interalia, a key cylinder.

In another embodiment, the key cylinder is adapted to allow the flow ofthe infusion liquid upon being actuated by the rotation of a key withinthe key cylinder.

In another embodiment, the infusion valve actuator may be adapted toremain attached to the valve after actuation. In another embodiment, theinfusion valve actuator may be adapted to disconnect from the valveafter actuation.

In another embodiment, the authentication unit may include, inter alia,a patient details acquisition unit, a liquid characteristics acquisitionunit, a comparison unit adapted to calculate a correlation value betweenthe details and the characteristics and a valve actuator control unitadapted to trigger an infusion valve actuator if the correlation valueis higher than a predetermined threshold value.

FIGS. 4 and 5 illustrate the infusion valve actuator (infusionactivation device) and its function according to some exemplaryembodiments of the invention. the information system may transmit, forexample, electronically, instructions to the activation device, forexample, after checking the patient's identification and the physician'sorders. The device may be instructed, for example, electronically, forexample, based on one or more of the previous actions, to be programmedto open or not to open the Shutoff Device, as described below.

According to some exemplary embodiments of the invention, the activationdevice may be reusable, may receive information regarding whether theinfusion or transfusion should proceed, and/or “order” the ShutoffDevice to open when drug administration is considered safe. FIG. 4illustrates that the activation device is actuated, meaning it hasreceived information to open the Shutoff Device. This device may nowinstruct the Shutoff Device to open and permit the infusion to commence.Once the infusion begins, the activation device can be removed forfurther use on this or other patients.

In the illustrations, the activation device is shown as a separate“smart card”, but other devices may be used as well. The activationdevice may even be an integral part of the information system, such aspart of the hand-held computer and not a separate device.

According to some exemplary embodiments, the activation device may havean “override” feature, which can be used, for example, in emergencysituations when infusion without data entry or verification (forexample, acute, massive hemorrhage) is necessary.

An Infusion Control Valve (Shutoff Device, “Smart Valve)

In another embodiment, the invention provides an infusion control valveadapted to be actuated by a valve actuator, wherein the valve actuatoris adapted to be triggered by an authentication unit. In anotherembodiment, the invention provides an infusion control valve adapted tobe actuated by a valve actuator, wherein the valve actuator is adaptedto be remotely triggered by an authentication unit.

In another embodiment, the valve is adapted to allow the flow of theinfusion liquid upon being actuated. In another embodiment, the valve isadapted to inhibit the flow of the infusion liquid when the valve is notactuated.

In another embodiment, the valve may include, inter alia, a keycylinder. In another embodiment, the key cylinder is adapted to allowthe flow of the infusion liquid upon being actuated by the rotation of akey within the key cylinder.

In another embodiment, the infusion valve is adapted to be actuated bythe valve actuator by mechanical, electrical, electromechanical,magnetic means or any combination thereof. In another embodiment, theinfusion valve may be adapted to be remotely actuated by the infusionvalve actuator.

In another embodiment, the valve may be disposable. In anotherembodiment, the valve may be made only from polymeric materials. Inanother embodiment, the valve may be made only from plastic materials.In another embodiment, the valve may be reusable. In another embodiment,the valve may be located outside the liquid path. In another embodiment,the valve may be located within the liquid path. In another embodiment,the valve may be located above the drip chamber. In another embodiment,the valve may be located below the drip chamber. In another embodiment,the valve may be conjugated to the drip chamber. In another embodiment,the valve may be mounted upon the drip chamber. In another embodiment,the valve may be located between an infusion bag and a pump. In anotherembodiment, the drip chamber may be referred to herein as a “spike”.

In another embodiment, the valve may be designed to inhibit the flow ofinfusion liquid during replacement of an infusion container. In anotherembodiment, the valve may be designed to inhibit the flow of infusionliquid during replacement of an infusion container by sealing the valveseal upon application of external pressure onto the valve during thereplacement of the infusion container. In another embodiment, the valveor the activation device may further include, inter alia, a counteradapted to count the number of infusion drops in the drip chamber.

The Shutoff Device (valve) and the activation device (valve actuator),according to some exemplary embodiments of the invention, may beillustrated in FIGS. 3, 4 and 5. In FIGS. 3 and 4, the valve is shown inthe “Closed” position, and the solutions in the infusion bag cannot beadministered to the patient. FIG. 3 shows the activation device beingput in proximity to the Shutoff Device. FIG. 4 shows that the activationdevice is actuated, that is, given the signal that theinfusion/transfusion may proceed. FIG. 5, shows the Shutoff Device inthe open position and the drug is being administered to the patient.Once a single infusion is completed, it can be reused a number of timeswhen changing infusions bags for the same therapeutic event. After eachbag change, the Shutoff Device may have to be reopened by repeating thesteps leading to activation of the activation device.

The Shutoff Device may be outside the infusion fluid path or within.According to some embodiments, the Shutoff Device may be positionedabove the drip chamber of the infusion set, as illustrated in FIG. 3, 4,5. The Shutoff Device may also be positioned between the drip chamberand the spike, and conjugated to them, as illustrated in FIG. 7.

According to other embodiments, the Shutoff Device may be positionedbelow the drip chamber. FIG. 6a illustrates, according to some exemplaryembodiments, Shutoff Device (101), positioned on infusion line (501),which is in fluid flow connection with drip chamber (103) and spike(201). According to this embodiment, Shutoff Device (101) is notconjugated to spike (201) and/or to drip chamber (103). According to anexemplary embodiment, Shutoff Device (101) may be positioned below dripchamber (103) and spike (201).

According to further embodiments, the Shutoff Device may be positionedabove the drip chamber of the infusion set and not conjugated to thedrip chamber and/or the spike. FIG. 6b illustrates, according to someexemplary embodiments, Shutoff Device (101) positioned on infusion line(501), which is in fluid flow connection with drip chamber (103) andspike (201). According to this embodiment, Shutoff Device (101) ispositioned between drip chamber (103) and spike (201) but not conjugatedto any of them. According to additional embodiments, other placementson, or in, the infusion line, or on the infusion bag, or a combinationof placements, are possible.

In the Figures herein, three possible non-limiting examples of ShutoffDevices are illustrated in detail. The invention may use one or all ofthese devices, or other devices that perform one or more of thefunctions described above.

Option 1, according to embodiments of the invention, provides a ShutoffDevice which is integrated into the infusion kit, specifically to thedrip chamber. In one embodiment of the invention, axial movement of theShutoff Device components may open and close the liquid path. In anotherembodiment, upon insertion of the infusion kit drip chamber to theinfusion bag, the components may move axially and the Shutoff Device maybe automatically closed. In another embodiment, a “key” may be used toopen the Shutoff Device. In another embodiment, the key may be a part ofthe activation device. In another embodiment, the key may be used as amanual override key in, for example, emergency situations. In anotherembodiment, rotation movement of the key in the Shutoff Device willresult in the opening thereof. Option 1 of the Shutoff Device, accordingto some exemplary embodiments of the invention, may be illustrated inFIGS. 7-14.

FIG. 7 illustrates, according to some exemplary embodiments, a shutoffdevice (101) which may be actuated or manually opened or closed by a key(102). The Shutoff Device (101) is designed as an integral part of thedrip chamber (103).

FIG. 8 illustrates, according to some exemplary embodiments, a shutoffdevice (101) having a spike (201) designed to penetrate into an infusionbag and having a key hole (202) adapted to be actuated or manuallyopened or closed by a key. The Shutoff Device (101) is designed as anintegral part of the drip chamber (103).

FIG. 9 illustrates, according to some exemplary embodiments, a crosssection of the shutoff device (101) having a spike (201) designed topenetrate into an infusion bag (104), through which the infusion liquid(303) may pass. The shutoff device (101) includes a locking element(301) which is adapted to change the position of a blocking element(302) which is presented in a closed position, is adapted to allow orinhibit the flow of the infusion liquid (303) when it is in an openedand closed position, respectively. The valve seal (304) is adapted toprevent liquid leaks. A key (102) is inserted in the key hole (202) andhas not yet rotated in the key hole.

FIG. 10 illustrates, according to some exemplary embodiments, a crosssection of the shutoff device (101) having a spike (201) designed topenetrate into an infusion bag, through which the infusion liquid (303)may pass. The key (102) is now starting to rotate (relative to itsposition illustrated in FIG. 10) but the locking element (301) has notchanged its position and blocking element (302) is still closed.

FIG. 11 illustrates, according to some exemplary embodiments, a crosssection of the shutoff device (101) having a spike (201) designed topenetrate into an infusion bag, through which the infusion liquid (303)may pass. The key (102) continues to rotate (relative to its positionillustrated in FIG. 10) and applies pressure on the locking element(301) and pushes it. The blocking element (302) is still closed.

FIG. 12 illustrates, according to some exemplary embodiments, a crosssection of the shutoff device (101) having a spike (201) designed topenetrate into an infusion bag, through which the infusion liquid (303)may pass. The key (102) continues to rotate (relative to its positionillustrated in FIG. 11) and causes the locking element (301) to changeits position by bending it away and thus opening the blocking element(302) and allowing the infusion liquid (303) to flow towards the dripchamber (103).

FIG. 13 illustrates, according to some exemplary embodiments, inaddition to the elements described in FIG. 12, the position of the key(102) relative to the key hole (202). The Key (102) may be removed andthe shutoff device may be remained in a opened position.

FIG. 14 illustrates a key (102), according to some exemplaryembodiments.

Option 2, according to embodiments of the invention, provides a ShutoffDevice which is an “inline” valve. According to another embodiment, theShutoff Device may be used with regular infusion kits. According toanother embodiment, one end of the Shutoff Device may be connected tothe infusion bag and the other end may be connected to the infusion kit.The working principal of the valve, according to some embodiments of theinvention may be similar to the working principal of option 1. Option 2of the Shutoff Device, according to some exemplary embodiments of theinvention, may be illustrated in FIGS. 15-17.

FIG. 15 illustrates, according to some exemplary embodiments, a shutoffdevice (401) which may be connected on one end to an infusion bag (104)and on the other end to a drip chamber (402) by a connecting element(403) which may be integral with the shutoff device (401). The shutoffdevice may be actuated or manually opened or closed by a key (102).

FIG. 16 illustrates, according to some exemplary embodiments, a crosssection of the shutoff device (401) having on one end a spike (404)designed to penetrate into an infusion bag (104), through which theinfusion liquid (303) may pass and on the other end a connecting element(403) designed to connect to a drip chamber (402). The shutoff device(401) includes a locking element (405) which is adapted to change theposition of a blocking element (406) which is presented in a closedposition, is adapted to allow or inhibit the flow of the infusion liquid(303) when it is in an opened and closed position, respectively. Thevalve seal (407) is adapted to prevent liquid leaks. A key (102) may beinserted and operate in a similar way as described in option 1.

Option 3, according to embodiments of the invention, provides a ShutoffDevice which is adapted to block the fluid flow by “pinching” theinfusion line. According to one embodiment of the invention, ShutoffDevice may be an add-on system on the infusion kit. In anotherembodiment, the axial movement of the drip chamber relative to thevalve's external parts may close the fluid flow. In another embodiment,upon insertion of the spike into the infusion bag the valve's componentsmay move axially and the valve may close automatically. In anotherembodiment, a key may be used to open the valve. Option 3 of the ShutoffDevice, according to some exemplary embodiments of the invention, may beillustrated in FIGS. 18-19.

FIG. 17 illustrates, according to some exemplary embodiments, a regularinfusion kit having an infusion bag (104), a drip chamber (402) and theinfusion line (501).

FIG. 18 illustrates, according to some exemplary embodiments, a shutoffdevice (502) placed on the drip chamber (402), having a pinchingmechanism (503) which may be operated by a key (102). The pinchingmechanism may pinch the infusion line (501) and block the liquid flow.

In another embodiment, the invention provides a method for delivering aninfusion including, inter alia, triggering an infusion valve actuatoradapted to actuate an infusion control valve. In another embodiment, theinvention provides a method for delivering an infusion including, interalia, remotely triggering an infusion valve actuator adapted to actuatean infusion control valve.

In another embodiment, the delivering may include, inter alia,intravenous administration. In another embodiment, the delivering mayinclude, inter alia, parenteral administration. In another embodiment,the delivering may include, inter alia, epidural administration. Inanother embodiment, the delivering may include, inter alia, intrathecaladministration. In another embodiment, the delivering may include, anyform of administration of any substance which substance needs to beidentified prior to administration.

In another embodiment, the method may further include, inter alia,removing the actuator from the valve after actuation.

FIGS. 19 and 20 describe flowcharts a according to some exemplaryembodiments of the invention.

FIG. 19 illustrates a flow chart of a method, according to someexemplary embodiments. Data relating to the patient and to theadministered liquid may be obtained and a correlation analysis betweenthe data sets may be conducted yielding a correlation value. If thecorrelation value is higher than a predetermined threshold value(V_(th)) the valve actuator is triggered. The valve actuator may open avalve, which was initially in a closed position. If the correlationvalue is lower than a predetermined threshold value (V_(th)) the valveactuator is not triggered.

FIG. 20 illustrates a flow chart of a method, according to someexemplary embodiments. Data obtained from a physician is loaded andoptionally transferred to a hand held computer. Data relating to thepatient and to the administered liquid may be scanned and a correlationanalysis between the data sets may be conducted yielding a match. Ifthere is no match, a correction is performed (for example, changing theinfusion to the right infusion or going to another patient). If there isa match, the result is displayed and the smart activator (valveactuator) is connected to the valve and opens it. The dosage timer maybe started. If the timer ends it may be reset. If the infusion bag isremoved or replaced (by disconnecting the spike) the valve may beautomatically closed and the medicine has to be rescanned. The smartactivator may or may not be disconnected from the valve. the valveactuator is triggered. The valve actuator may open a valve, which wasinitially in a closed position. If the correlation value is lower than apredetermined threshold value (V_(th)) the valve actuator is nottriggered.

In one embodiment of the invention, the term “infusion” may be definedas any substance adapted for administration to a subject. In anotherembodiment the substance may be a liquid. In another embodiment thesubstance may include particles. In another embodiment the substance mayinclude a gel. In another embodiment, the infusion may be adapted forintravenous administration. In another embodiment, the infusion may beadapted for parenteral administration. In another embodiment, theinfusion may be adapted for epidural administration. In anotherembodiment, the infusion may be adapted for intrathecal administration.In another embodiment, the infusion may be adapted for any form ofadministration of any substance which substance needs to be identifiedprior to administration. In another embodiment, the term infusion mayinclude transfusion.

In another embodiment, the term infusion as referred to herein mayinclude, inter alia, saline, a drug, a pharmaceutical composition,blood, a blood product, a blood component, plasma, a plasma derivative,a biological substance, total parenteral nutrition (TPN), anycombination thereof or any other substance that is adapted to be may beadministered to a subject. In another embodiment, the drug may include,inter alia, a chemotherapeutic agent, antibiotics, anesthetics, anycombination thereof or any other substance that is adapted to be may beadministered to a subject.

In one embodiment of the invention, the term “infusion” may refer to adrip infusion. In another embodiment, the term “drip infusion” may referto a gravitation infusion. In another embodiment, the term “gravitationinfusion” may refer to an infusion wherein the liquid is flowing bygravity. In another embodiment, the term “infusion” may refer to anon-pumped infusion. In another embodiment, the term “infusion” mayrefer to a pumped infusion. In one embodiment of the invention, the term“actuate” may refer to any type of activation of another element. Inanother embodiment, the term “actuate” may refer to open.

In one embodiment of the invention, the term “valve” may refer to anyapparatus which may be opened or closed. In another embodiment, thevalve may be adapted to allow more than one flow rates.

In one embodiment, the term “infusion control valve” according to theinvention, may also be referred to as a “shutoff device” or a “SmartValve”.

In one embodiment of the invention, the term “key” may refer to anyapparatus which is adapted to induce opening or closing of a valve,mechanically, electrically, electromechanically, magnetically,electromagnetically or by any other appropriate way.

In one embodiment of the invention, the term “infusion valve actuator”may also be referred to as an infusion activation device or a “SmartActivator”.

While certain features of the invention have been illustrated anddescribed herein, many modifications, substitutions, changes, andequivalents may occur to those of ordinary skill in the art. It is,therefore, to be understood that the appended claims are intended tocover all such modifications and changes as fall within the true spiritof the invention.

What we claim is:
 1. An infusion control valve functionally connected toan authentication unit; wherein said infusion control valve is normallyclosed thereby preventing an infusion liquid from reaching a patient;and wherein said authentication unit is configured to trigger opening ofsaid valve when said authentication unit identifies a match between saidpatient and said infusion liquid, thereby initiating flow of saidinfusion liquid to the patient, wherein said infusion control valve ispositioned above or below a drip chamber of an infusion line.
 2. Thevalve of claim 1, wherein said authentication unit is configured toremotely trigger the opening of said infusion control valve.
 3. Thevalve of claim 2, wherein remotely triggering comprises utilizing IR,RF, ultrasound or any combination thereof.
 4. The valve of claim 1,wherein said valve comprises a key cylinder, wherein said key cylinderis adapted to allow the flow of the infusion liquid upon being actuatedby the rotation of a key within said key cylinder.
 5. The valve of claim1, wherein said authentication unit comprises a patient detailsacquisition unit, a liquid characteristics acquisition unit, acomparison unit, adapted to match the patient details to the liquidcharacteristics.
 6. The valve of claim 5, wherein said authenticationunit is configured to identify the match between the patient and theinfusion liquid by calculating a correlation value between said patientdetails and said liquid characteristics and to compare said correlationvalue to a predetermined threshold value.
 7. The valve of claim 1,wherein said valve is adapted to be actuated by a valve actuator bymechanical, electrical, electromechanical, magnetic means or anycombination thereof.
 8. The valve of claim 1, wherein said valve isdisposable.
 9. The valve of claim 1, wherein said valve is reusable. 10.The valve of claim 1, wherein said valve is located outside the liquidpath.
 11. The valve of claim 1, wherein said valve is located within theliquid path.
 12. The valve of claim 1, wherein said valve is designed toinhibit the flow of infusion liquid during replacement of an infusioncontainer.
 13. The valve of claim 1, wherein said valve is positionedbetween said drip chamber and a spike but not conjugated to any of them.14. A method for delivering an infusion liquid to a patient, the methodcomprising utilizing an authentication unit to identify a match betweenthe patient and the infusion liquid and triggering opening of aninfusion control valve if a match is identified, thereby initiating flowof the infusion liquid to the patient wherein said infusion controlvalve is positioned above or below a drip chamber of an infusion line.15. The method of claim 14, wherein triggering opening of said infusioncontrol valve is done remotely.
 16. The method of claim 15, whereinremotely triggering comprises using IR, RF, ultrasound or anycombination thereof.
 17. The method of claim 14, wherein said deliveringcomprises intravenous administration.
 18. The method of claim 14,wherein said delivering comprises parenteral, epidural, intrathecaladministration or any combination thereof.
 19. The method of claim 14,wherein said infusion comprises saline, a drug, a pharmaceuticalcomposition, blood, a blood product, a blood component, plasma, a plasmaderivative, a biological substance, total parenteral nutrition (TPN) orany combination thereof.
 20. The method of claim 19, wherein said drugcomprises a chemotherapeutic agent, antibiotics, anesthetics or anycombination thereof.
 21. The method of claim 14, wherein triggeringopening of said infusion control valve comprises utilizing a valveactuator adapted to actuate said valve by mechanical, electrical,electromechanical, magnetic means or any combination thereof.
 22. Themethod of claim 21, wherein said valve comprises a key cylinder.
 23. Themethod of claim 22, wherein said key cylinder is adapted to allow theflow of the infusion liquid upon being actuated by the rotation of a keywithin said key cylinder.
 24. The method of claim 14, whereinidentifying a match between the patient and the infusion liquidcomprises comparing patient details to characteristics of the infusionliquid.
 25. The method of claim 24, wherein comparing the patientdetails to the characteristics of the infusion liquid comprisescalculating a correlation value and comparing the correlation value to apredetermined threshold value.
 26. An infusion control system comprisingan infusion control valve and valve an authentication unit; wherein saidinfusion control valve is normally closed thereby preventing an infusionliquid from reaching a patient; and wherein said authentication unit isconfigured to trigger opening of said valve when identifying a matchbetween said patient and said infusion liquid, thereby initiating flowof said infusion liquid to the patient, wherein said infusion controlvalve is positioned above or below a drip chamber of an infusion line.27. The infusion control system of claim 26, wherein said authenticationunit is adapted to actuate said valve remotely.
 28. The infusion controlsystem of claim 27, wherein remotely triggered comprises means of IR,RF, ultrasound or any combination thereof.
 29. The infusion controlsystem of claim 26, wherein said authentication unit is configured totrigger opening of said infusion control valve by actuating a valveactuator configured to actuate the opening of the infusion control valveby mechanical, electrical, electromechanical, magnetic means or anycombination thereof.
 30. The infusion control system of claim 26,wherein said infusion control valve comprises a key cylinder.
 31. Theinfusion control system of claim 30, wherein said key cylinder isadapted to allow the flow of the infusion liquid upon being actuated bythe rotation of a key within said key cylinder.
 32. The infusion controlsystem of claim 26, wherein said authentication unit comprises a patientdetails acquisition unit, a liquid characteristics acquisition unit, acomparison unit, and wherein identifying the match between said patientand said infusion liquid comprises, utilizing said comparison unit tocalculate a correlation value between patient details stored in saidpatient acquisition unit and liquid characteristics identified by saidpatient acquisition unit.